ID

27836

Descrizione

NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Keywords

versioni (2)
  1. 30/11/17 30/11/17 -
  2. 04/01/18 04/01/18 -
Titolare del copyright

Prof. Dr. med. Georg Heß

Caricato su

30 novembre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

Inglese

Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 moduli  
Admininstrative data
Descrizione

Admininstrative data

Subject ID
Descrizione

Subject ID

Tipo di dati

text

Inclusion Criteria
Descrizione

Inclusion Criteria

1. Patients aged >=18 years
Descrizione

Age

Tipo di dati

boolean

Trial Protocol Version 1.0: 2. CD20 positive disease
Descrizione

Trial Protocol Version 2.0: Criterion 2 removed.

Tipo di dati

boolean

3. Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
Descrizione

Diagnosis of lymphoma

Tipo di dati

boolean

4. Relapsed disease
Descrizione

Relapsed disease

Tipo di dati

boolean

5. ECOG performance status =< 2, unless tumor associated
Descrizione

ECOG performance status

Tipo di dati

boolean

Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
Descrizione

LVEF

Tipo di dati

boolean

Trial protocol Version 2.0: 6. Adequate cardiac reserve
Descrizione

Serum troponin level must be consistent with no significant acute or chronic myocardial damage and there should be no evidence of symptomatic disease

Tipo di dati

boolean

7. No curative option available
Descrizione

No curative option available

Tipo di dati

boolean

8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
Descrizione

tumor mass

Tipo di dati

boolean

9. Signed informed consent
Descrizione

Signed informed consent

Tipo di dati

boolean

10. Adequate bone marrow reserve / hepatic and renal function
Descrizione

Adequate bone marrow reserve: - Platelets of at least 100.000/μl (in case of extensive BM-Infiltration 75.000/μl may be acceptable after discussion with the coordinating investigator); - absolute neutrophil count of at least 1000/μl . Adequate hepatic and renal function: - ALT < 2.5 x upper limit of normal (ULN); - AST < 2.5 x ULN; - total Bilirubin < 1.5 x ULN.

Tipo di dati

boolean

11. No active Hepatitis B or C or HIV-infection
Descrizione

Infections

Tipo di dati

boolean

12. Measured or calculated creatinine clearance > 30 ml/min
Descrizione

creatinine clearance

Tipo di dati

boolean

13. Fresh tumor biopsy or archived tissue available
Descrizione

Fresh tumor biopsy or archived tissue

Tipo di dati

boolean

14. Ability of patient to understand nature, importance and individual consequences of clinical trial
Descrizione

Understanding patient

Tipo di dati

boolean

15. Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (Serum or Urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment.
Descrizione

Reliable contraception comprises systematic contraceptives (oral, implant, injection) or diaphragm / condoms /intrauterine devices (IUP) with spermicide.

Tipo di dati

boolean

16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
Descrizione

contraception male patients

Tipo di dati

boolean

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Similar models

Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Admininstrative data
Subject ID
Item
Subject ID
text
Item Group
Inclusion Criteria
Age
Item
1. Patients aged >=18 years
boolean
CD20 positive disease
Item
Trial Protocol Version 1.0: 2. CD20 positive disease
boolean
Diagnosis of lymphoma
Item
3. Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
boolean
Relapsed disease
Item
4. Relapsed disease
boolean
ECOG performance status
Item
5. ECOG performance status =< 2, unless tumor associated
boolean
LVEF
Item
Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
boolean
Adequate cardiac reserve
Item
Trial protocol Version 2.0: 6. Adequate cardiac reserve
boolean
No curative option available
Item
7. No curative option available
boolean
tumor mass
Item
8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
boolean
Signed informed consent
Item
9. Signed informed consent
boolean
bone marrow reserve hepatic and renal function
Item
10. Adequate bone marrow reserve / hepatic and renal function
boolean
Infections
Item
11. No active Hepatitis B or C or HIV-infection
boolean
creatinine clearance
Item
12. Measured or calculated creatinine clearance > 30 ml/min
boolean
Fresh tumor biopsy or archived tissue
Item
13. Fresh tumor biopsy or archived tissue available
boolean
Understanding patient
Item
14. Ability of patient to understand nature, importance and individual consequences of clinical trial
boolean
Pregnancy ruled out
Item
15. Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (Serum or Urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment.
boolean
contraception male patients
Item
16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
boolean
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